Closed-Loop Impact on Chronic Kidney Disease in Type 2 Diabetes

NCT06925217 | Recruiting

• 1 other identifier: CLICK
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study is to evaluate the effect of fully automated closed-loop glucose control on renal tissue oxygenation among people with type 2 diabetes and chronic kidney disease. This is a single-center, open-label parallel design study that will compare 26 weeks of fully-automated closed-loop glucose control with standard insulin therapy and continuous glucose monitoring, following a run-in period. A total of up to 76 adults with type 2 diabetes and chronic kidney disease will be recruited through outpatient diabetes and nephrology clinics. The primary outcome is renal tissue oxygenation measured using blood oxygenation level-dependent magnetic resonance imaging at 26 weeks. Other key outcomes include glycated hemoglobin at 26 weeks and time spent with glucose levels within and above the target glucose range (3.9-10.0mmol/L). Other glycemic and renal outcomes (including renal function) will also be assessed, as well as patient-reported outcome measures using validated questionnaires. Safety evaluations include severe hypoglycemic episodes and other adverse and serious adverse events.

Conditions

Chronic Kidney Disease Stage 3; Type 2 Diabetes

Keywords

closed-loop; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Cortical renal tissue oxygenation (R2*)

  Measured using BOLD-MRI

  at 26 weeks

Secondary Outcomes (19)

• Proportion of time spent in the target glucose range (3.9 to 10.0mmol/l)

  over 26 weeks

• Glycated hemoglobin

  at 26 weeks

• Proportion of time spent above target glucose (>10.0mmol/l)

  over 26 weeks

• Mean sensor glucose

  over 26 weeks

• Non-inferiority for time spent below target glucose (<3.9mmol/L)

  over 26 weeks

Study Arms (2)

Fully closed-loop insulin delivery (CamAPS HX)

EXPERIMENTAL

The CamAPS HX closed-loop system will consist of : * mylife Ypsopump insulin pump (Ypsomed, Switzerland) * FreeStyle Libre 3 CGM (Abbott, USA) * Cambridge model predictive control algorithm on a smartphone (CamAPS, UK) * Cloud upload system to review CGM/insulin data

Device: CamAPS HX

Standard insulin therapy with CGM

ACTIVE COMPARATOR

Participants in the control arm will continue their standard insulin therapy. They will also receive a Freestyle Libre 3 glucose sensor (Abbott, USA).

Device: Standard insulin therapy with CGM

Interventions

CamAPS HX DEVICE

The CamAPS HX fully closed-loop system consists of an insulin pump, a continuous glucose monitoring (CGM) sensor, as well as the CamAPS HX app, which resides on a smartphone and communicates wirelessly with the insulin pump.

Fully closed-loop insulin delivery (CamAPS HX)

Standard insulin therapy with CGM DEVICE

Participants will continue their standard insulin therapy with a Freestyle Libre 3 CGM

Standard insulin therapy with CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed by the subject
• Age 18 years and older
• Type 2 diabetes diagnosed for at least 12 months
• Treatment with insulin therapy for at least 6 months
• CKD defined either as an eGFR 30-59 ml/min/1.73m² or presence of albuminuria \> 3 mg/mmol (stage A2 or A3 according to KDIGO) with an eGFR \> 30 ml/min/1.73m². CKD must be present for at least 6 months.
• HbA1c \< 12% based on a venous blood sample from the screening visit
• Receiving treatment with an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, have been offered these therapies previously, or contraindication/intolerance to receiving these therapies
• Willing to wear study devices and follow study instructions
• Capable of giving an informed consent

You may not qualify if:

• Type 1 diabetes
• Current use of insulin pump
• Current use of any closed-loop system
• Alternative cause of CKD according to medical records such as polycystic kidney disease, glomerulonephritis, congenital urogenital tract diseases, etc.
• Known or suspected allergy against insulin
• Pregnancy, planned pregnancy, or breast feeding
• Severe visual impairment
• Severe hearing impairment
• Two or more episodes of severe hypoglycemia in the last 6 months
• Medically documented allergy towards the adhesive (glue) of plasters
• Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
• Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
• Recent (less than three months) history of myocardial infarction, percutaneous coronary intervention, stroke, or hospitalization for heart failure with reduced ejection fraction
• History of renal transplantation requiring ongoing immunosuppressive therapy
• Known or suspected non-compliance, drug or alcohol abuse

Sponsors & Collaborators

• Heba Al-Alwan: lead
• Swiss National Science Foundation, Switzerland: collaborator
• Institute of Primary Health Care (BIHAM), Switzerland: collaborator

Study Sites (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

NOT YET RECRUITING

CHUV

Lausanne, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Heba Al-Alwan, MD, PhD

CONTACT

+4179 556 27 98; heba.al-alwan@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 13, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)